Clinical trial NCT02911337: Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Official title: Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Diastolic
Weight Loss
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30
* Able to perform 6 minute hall walk test
* Left Ventricular ejection fraction \>45%
* Diagnosis of heart failure with preserved ejection fraction (HFpEF) ; confirmation of HFpEF based on 1 major or 3 minor criteria listed below.

Major:

1. Elevated BNP \>200
2. cardiogenic pulmonary edema
3. Pulmonary capillary wedge pressure at rest \>15 mmhg or with exercise \>25 mmhg using invasive right heart pressure measurement

Minor:

1. Left atrial enlargement (volume \>68 ml)
2. increased left ventricular wall thickness (\>1.1cm) by echocardiography
3. E/e' \>15
4. intermediate level of BNP, 60-199

Exclusion Criteria:

* uncontrolled blood pressure
* severe chronic obstructive pulmonary disease (oxygen or steroid dependent)
* recurrent major depression. presence or history of suicide behavior, and current substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months
* other major psychiatric illness (schizophrenia, bipolar, dementia)
* significant hepatic dysfunction
* untreated hypothyroidism or hyperthyroidism
* history of drug or alcohol abuse or dependency within the past 12 months
* acute coronary syndrome without revascularization in the past 12 months
* acute coronary syndrome with revascularization in the past 6 months
* Cerebrovascular accident or transient ischemic attack in the past 6 months
* cancer or terminal illness with life expectancy \< 3 years
* history of medical noncompliance
* significant anemia (hgb \<9)
* life threatening or uncontrolled arrhythmia
* hemodynamically relevant valvular heart disease
* infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease
* genetic hypertrophic cardiomyopathy
* significant pericardial disease
* clinically relevant neuromuscular disease
* pregnant or may become pregnant in the next 6 months
* prior major organ transplant or intent to transplant ( on the transplant list)
* pacemaker dependant
* clinically significant congenital heart disease that may be cause of symptoms

Primary outcomes:
measure: Change in 6 minute hall walk test from baseline
timeFrame: 6 months
measure: Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
timeFrame: 6 months
Secondary outcomes:
measure: Left Ventricular mass
timeFrame: 6 months
measure: Brain Natriuretic Peptide
timeFrame: 6 months
Other outcomes:
measure: Left Atrial Volume
timeFrame: 6 months
measure: Early mitral inflow velocity/mitral annular velocity (E/e')
timeFrame: 6 months
Locations:
city: Charleston
country: United States
facility: MUSC Gazes Research Institue
state: South Carolina
Study officials:
References:
citation: El Hajj EC, El Hajj MC, Sykes B, Lamicq M, Zile MR, Malcolm R, O'Neil PM, Litwin SE. Pragmatic Weight Management Program for Patients With Obesity and Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Nov 2;10(21):e022930. doi: 10.1161/JAHA.121.022930. Epub 2021 Oct 29.