N/A
N=80
Improving Metabolic Health in Patients With Diastolic Dysfunction
Obesity · Heart Failure, Diastolic · Metabolic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03448185 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Change From Baseline at 1 Year in Myocardial Lipid Content — -0.16; -0.18; -0.53; -0.19 %fat/water
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High intensity exercise (Behavioral); Omega-3 fish oil (Dietary_supplement); Yoga (Behavioral); olive oil capsules (Dietary_supplement)
- Age
- Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 1 Year in Myocardial Lipid Content |
-0.16; -0.18; -0.53; -0.19 | — |
| SECONDARY Change From Baseline at 1 Year in Peak Volume of Oxygen (VO2) |
0.21; 4.39; -0.03; 4.53 | — |
| SECONDARY Change From Baseline at 1 Year in Markers of Arterial Stiffness |
-15; -16; 32; -7 | — |
| SECONDARY Change From Baseline at 1 Year in Left Ventricular Mass |
0.2; 7.2; -5.8; 6.0 | — |
Summary
The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.
Eligibility Criteria
Inclusion Criteria
- ejection fraction >0.50
- >2.0 kg visceral fat (intra- and retro-peritoneal adipose tissue)
- either a high sensitivity troponin (>0.6pg/ml), or NTBNP (>40 ng/ml)
- age range 40 -60
- BMI range 30 - 50 kg/m2
Exclusion Criteria
- age 60
- body mass index > 50, < 30 kg/m2
- history of insulin dependent diabetes, heart failure, myocarditis, restrictive cardiomyopathy, permanent/persistent atrial fibrillation, severe chronic obstructive pulmonary disease, unstable coronary artery disease or recent (<12 month) acute coronary syndrome, cerebrovascular disease as evidenced by prior transient ischemic attack or stroke and active/recent tobacco use (quit < 5 years).
- Female patients will be excluded if they are pregnant or plan to become pregnant (expected rare occurrence in the selected age range of 40 - 60). 5. Patients will be excluded if they are taking non-statin lipid lowering agents (fibrates, niacin, or fish oils)
- Contra-indications to MRI
Data sourced from ClinicalTrials.gov (NCT03448185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.