A Defined, Plant-Based Diet and Other Integrative Therapies Improve Functional Status and Ejection Fraction while Reducing Medications in Patients With Heart Failure: A Case Series

Abstract

Heart failure with reduced ejection fraction (HFrEF) is a major contributor of premature cardiovascular-related deaths. Patients are typically on numerous medications to manage this condition; however, patients continue to experience poor quality of life. Alternative therapeutic approaches are needed to treat HFrEF. The clinical course of seven patients with Stage C and D HFrEF who failed guideline-directed medical therapy were retrospectively analyzed based on medical chart data. All patients consumed a defined, plant-based diet as part of their clinical treatment, and a subset also underwent alternative treatment modalities: External Counterpulsation therapy, BEMER therapy, infrared sauna therapy, ozone therapy, or PlaqueX® therapy. Chart review of these patients indicated improvement in left ventricular ejection fraction (LVEF) and right ventricular systolic pressure (RVSP). All patients also had a significant reduction in medication needs and body weight. Further, all patients reported significant improvements in their quality of life. These data suggest that a defined, plant-based diet combined with other alternative modalities may be efficacious in reducing HFrEF medications and treating Stage C or D HFrEF patients who failed guideline-direct medical therapies. Observations from this case series indicate a need for rigorous prospective studies to confirm these effects.

“Nutrition is the foundation of our integrative heart failure therapy, and therefore, it is the common denominator of treatments.”

Introduction

In the United States, approximately 6.7 million individuals over the age of 20 have a diagnosis of congestive heart failure with reduced ejection fraction (HFrEF); this prevalence is expected to rise to 8.5 million by the year 2030. ¹ The lifetime risk factor of heart failure has increased to 24% and if current trends hold 1 in 4 people will develop heart failure in their lifetime. ¹ Current treatment guidelines employ various pharmaceutical and non-pharmaceutical therapies to treat HFrEF. ² Despite the many advances in heart failure therapies, more than 12% of heart failure patients are classified as either stage C or D heart failure.^3-5 These individuals can have significant symptoms of heart failure despite optimal medical therapy and require frequent hospitalizations. Patients in these categories typically progress to the point of needing advanced therapies such as left ventricular assist devices (LVADs) and heart transplants. Disease progression in heart failure patients is often accompanied by additional complications, increasing health care costs, and elevated risks for premature mortality.

Data from an earlier case series of three patients with HFrEF indicated a defined plant-based diet (DPBD) was associated with improvements in cardiac function and hemodynamics, in addition to reductions in the need for patient medications. ⁶ In addition to DPBD, other alternative, nonmedical therapies have emerged in recent years. Beneficial cardiovascular effects have been observed with infrared sauna therapy (IFS),^7,8 enhanced external counterpulsation therapy (ECP),^9,10 ozone and ultraviolet blood irradiation (UBI),^11-13 polyunsaturated phosphatidylcholine (PC) infusion, as well as bio-electro-magnetic-energy regulation (BEMER) therapy.^14-19 The current retrospective case series study examines the clinical course of seven acutely ill HFrEF patients (Stage D) who presented to an outpatient integrative cardiac center with worsening symptoms of HFrEF, despite being on optimal guideline-directed medical and nonmedical therapies. These patients consumed a DPBD along with one or more regenerative therapies integrated with limited allopathic heart failure therapies.

Methods

Study Population and Patient Presentations

Patients for this retrospective case series were seen at Montgomery Heart & Wellness, an outpatient cardiovascular clinic in Houston, Texas and were selected via electronic chart review within a 2-year period (2022-2023). To be included in this analysis, patients must have met all three of the following criteria: 1) Patients must have had HFrEF (Stage C or D), 2) they must have failed guideline-directed medical therapies (GDMT), and 3) they must have elected to consume the DPBD. HFrEF patients who were not failing GDMT or who were not treated with DPBD were not selected for this case series report. Since this was a retrospective analysis, patients were each treated on an individual basis and were not treated as a study group. Their ages ranged from 46 to 82 years (Table 1). All patients were carefully monitored for signs of malnutrition based on bloodwork and clinical observation.

Table 1.

Baseline Demographics.

Patient	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7
Gender	Male	Female	Female	Male	Male	Female	Male
Ethnicity	White	African American	White	African American	African American	White	African American
Age (y)	63	74	61	61	46	82	52
Smoking status	Never	Never	Former (5 pack year history)	Never	Never	Never	Never
Alcohol Consumption	No	No	No	Red wine on the weekends	No	No	No
Diet	SAD	SAD	Keto	Chicken, vegetables, rice	SAD, recently eating some plant-based foods	SAD, recently eating some plant-based foods	SAD
Exercise	No	No	No	Jogging 30 min 3 times a week, some mild weightlifting	No	No	No
BMI (kg/m2)	43	19	26	31	31	17	37
SBP (mm/hg)	123	143	117	172	135	103	138
DBP (mm/hg)	67	68	84	89	95	70	93
HR (beats/min)	81	63	111	64	91	91	104
Medical history	Hypertension, diabetes, coronary artery disease, congestive heart failure	Left bundle branch block, dilated cardiomyopathy, congestive heart failure, atherosclerosis, hypertension	Postpartum cardiomyopathy, severe mitral regurgitation, hepatic congestion, congestive heart failure, former tobacco use	Coronary artery disease with coronary artery bypass x 3, congestive heart failure, hypertension, hyperlipidemia	Coronary artery disease with stent placement, congestive heart failure, gout, hepatic cirrhosis, type 2 diabetes	Coronary artery disease with recent infarction and stent, congestive heart failure, pleural effusion, severe mitral regurgitation, stage IV CKD.	Congestive heart failure, atrial fibrillation, NSTEMI, nephrotic syndrome and stage III CKD, hypertension, sleep apnea on CPAP, pulmonary hypertension on home oxygen, bilateral leg lymphedema
Medications	Aspirin 81 mg once a day, bisoprolol 10 mg twice a day, valsartan 160 mg once a day, atorvastatin 80 mg once a day in the evening, ranolazine 500 mg ER once a day, clopidogrel 75 mg once a day, Ozempic® 2 mg/1.5 mL (0.5 mg dose) solution as directed subcutaneously once a week, insulin pump, and vitamin D2 50 000 IU units capsule once a week	Entresto® 24-26 mg tablet twice a day, furosemide 40 mg tablet twice a day, potassium chloride 10 mEq once a day, and carvedilol 25 mg tablet twice a day	Metoprolol tartrate ½ tablet of 25 mg twice a day, Lasix® 20 mg once a day and potassium chloride 10 mEq extended release once a day, Farxiga® 10 mg one tablet once a day, and digoxin 125 mcg two tablets once a day	Nebivolol 5 mg once a day, aspirin 81 mg once a day, Xarelto® 2.5 mg twice a day, ranolazine 1000 mg ER twice a day, and rosuvastatin 20 mg once each evening	Rosuvastatin 40 mg tablet 1 tab(s) orally once a day Allopurinol 100 mg tablet take 1 tablet twice a day, Eliquis® 5 mg tablet take 1 tablet twice a day, Jardiance® 10 mg tablet 1 tab(s) orally once a day (in the morning) Entresto® 24/26 mg tablet 1 tablet by mouth twice a day, furosemide 80 mg tablet, take 1 tablet twice a day, and Lantus® 100 units/ml inject 18 units once a day	Milrinone 1 mg/mL infusion 0.375 mcg/kg/hr, furosemide 20 mg once a day, Eliquis® 2.5 mg, Plavix® 75 mg once daily, NP Thyroid dessicated 60 mg once a day	Cinacalcet 30 mg tablet 1 tablet once a day, amiodarone 200 mg tablets 1 tablet once a day, warfarin 5 mg tablet, take 1 tablet once daily on Mon, Wed, Fri, Sat and Sun and take 1.5 tablets on Tue and Thu, nifedipine 30 mg extended release 1 tablet once a day, bumetanide 1 mg tablet 1 tablet orally every other day, hydralazine hydrochloride and isosorbide dinitrate 37.5 mg – 20 mg tablet take 2 tablets three times a day

Abbreviations: BMI, body mass index; CKD, chronic kidney disease; SAD, standard American diet; NSTEMI, non-ST-elevation myocardial infarction.

Weekly Visits

Patients were evaluated at least once a week during the first month of intervention. Depending on the acuity of their illness and nature of their intervention, some patients were seen as much as 3-5 times a week. Patients were also followed closely by phone by the onsite digital health center. After the first month, they were evaluated at least once a month. All patients were treated with a DPBD (Level 0-4b for six patients and Level 0-6 for one patient, Table S1); however, some patients also completed other alternative integrative therapies (Table 2). These alternative treatment modalities were selected based on a number of criteria, including patient preference based on their availability, available financial resources, and individual choice. Treatment times ranged from 37 to 330 days (Table 3), with a mean of 134.14 days (SD = 84.81). Additional methods can be found in the supplementary materials.

Table 2.

Patient Treatments.

	DPBD	EBOO	UBI	Infrared Sauna	ECP	BEMER	Phosphatidylcholine
Patient 1	X			X		X
Patient 2	X
Patient 3	X
Patient 4	X			X	X	X
Patient 5	X	X		X		X	X
Patient 6	X		X	X		X	X
Patient 7	X

Table 3.

Total Intervention Time for Each Patient.

Patient	Days of Intervention
Patient 1	127
Patient 2	117
Patient 3	106
Patient 4	124
Patient 5	37
Patient 6	330
Patient 7	98
Average	134

Results

Patient Clinical Course

Overall, LVEF trended towards an increase from baseline (Figure 1), although statistical significance was not reached (P = 0.08). Due to Patient 6’s worsening condition, the removal of milrinone was required which resulted in LVEF reduction Figue S1. As such, a separate analysis of LVEF without patient 6 was conducted (Figure 1B); this analysis resulted in a significant increase in overall LVEF (+37%, P = 0.0071). In addition, RVSP trended towards a 21% reduction (P = 0.0548) following the intervention (Figure 1C). There was also a significant reduction in body weight (−12%, Figure 1D) following the intervention (P = 0.034), and a significant reduction in medication usage (Table S2, Figure 1E; −55%, P = 0.0004). No significant changes were observed in other clinical parameters (Figure 1(F)–(K)). In addition, quality of life drastically improved for all patients (Table 4). Patient-specific outcomes and additional results can be found in the supplementary materials.

Figure 1.

Clinical changes in subjects from baseline (pre) to final (post). (A–C) LVEF and RVSP were quantified via echocardiogram. LVEF data is presented with (A) and without (B) patient 6. (F–H) SBP, DBP, and HR were determined with an automated sphygmomanometer. (I–K) was measured by external laboratory analysis.

Table 4.

Changes in Symptoms and Quality of Life Among Patients.

Patient	Baseline Symptom Characteristics	Final Symptom Characteristics
Patient 1	Fatigue	Exercised 3-5 days a week (aerobic and weightlifting)
	Shortness of breath	No shortness of breath
	No exercise abilities
Patient 2	Palpitations	Resolution of palpitations
	Shortness of breath if missed diuretics	No shortness of breath off diuretics
Patient 3	Leg edema	Resolution of leg edema
	Shortness of breath walking less than 10 minutes	Walks 30 minutes or more daily without shortness of breath
Patient 4	Can perform 5 burpees	Can perform 20 burpees
	Chest pain	Eradication of chest pain
	Sensation of “pulling” on the neck with exercise	Eradication of neck “pulling”
Patient 5	Shortness of breath with rest	Shortness of breath with moderate activity
	Orthopnea	No orthopnea
	Severe abdominal bloating	Mild abdominal bloating
	Leg edema	No leg edema
Patient 6	Dependence on wheelchair	Can walk one hour without assistance device
	Shortness of breath at rest	No shortness of breath off diuretics
	Orthopnea with cough	No orthopnea or cough
Patient 7	Dependence on supplemental oxygen	Off supplemental oxygen at rest for small periods of time
	Leg edema	No leg edema

Discussion

We illustrate in this small, retrospective case series that a DPBD along with other integrative therapies was effective in improving heart failure while simultaneously reducing heart failure-managing medications. Considering the dramatic improvement in the quality of life of these patients (Table 4), these findings are noteworthy. Although the sample size and treatment duration limit the conduct of formal outcome analyses, this patient group experienced a positive clinical course consisting of overall clinical improvement. Despite a reduction of body weight in patients 2 and 6 who were already of low body mass index (BMI), they improved both from a clinical perspective and quality of life perspective. Patient 6, for example, was wheelchair-bound prior to the intervention and was able to walk and hike following the intervention. All seven patients had improvement in their functional status with increased exercise tolerance and an overall improved quality of life. The universal clinical improvement of this patient group strongly supports the likelihood that the nutritional and regenerative intervention had a positive clinical impact. Furthermore, the relatively short average treatment duration of 134 days in this cohort supports the likelihood that this intervention had a relatively immediate effect in this acutely ill population.

A contributing factor to these patients’ underlying illness is the fact that they were on an average of 6 medications each. While they were all on some form of guideline-directed medical therapy for heart failure, the underlying complex drug-to-drug interactions could contribute to adverse biochemical and or physiological effects. ²⁰ Indeed, simply reducing one medication in the setting of polypharmacy reduces CVD mortality by 17%. ²¹ Illustrating this further, frequent and regular diuretic use can lead to intravascular volume depletion and electrolyte deficiencies, resulting in compromised overall cardiac output due to impaired filling pressures, myocardial dysfunction, and cardiac arrhythmias. The use of statin drugs in patients with underlying coronary disease and hyperlipidemia may result in impaired mitochondrial function,^22,23 possibly worsening overall LV function. Therefore, medication reduction was an important part of the intervention. We also found that the DPBD could act as an alternative to statins by reducing LDL-C by 24.6 mg/dL (∼17%) and hs-CRP by 2.4 mg/L (∼32%). ²⁴

We are unable to determine the relative efficacy of the various treatment modalities in the present case series due to the small sample size. However, evidence suggests that these alternative modalities are all effective in treating CVD and HFrEF, hence, our use of these modalities.^7-14,17-19 Nonetheless, nutrition is the foundation of our integrative heart failure therapy, and therefore, it is the common denominator of treatments. These clinical observations raise important questions about the potential benefits of these integrative therapies in the HFrEF population. Future, well-planned, prospective studies could evaluate these questions and add to this area of medicine.

Conclusion

This case series demonstrates that a DPBD and regenerative therapy integrated with limited and targeted allopathic drugs can result in clinical improvements in stage C and D heart failure patients who remained symptomatic while on guideline-directed medical and surgical therapies. The potential safety and efficacy of this intervention for this critically ill population is an important observation and needs further evaluation in a randomized prospective study. Such a study is needed to elucidate the mechanisms and relative importance of the various interventions used in this case series.

ORCID iD

Rami S. Najjar https://orcid.org/0000-0001-5348-3008

Data Availability Statement

All raw data can be obtained at the following DOI: 10.6084/m9.figshare.25215836.