A Study to Examine if People Without HFpEF Display Less Visceral Adipose Tissue (VAT) Compared to Patients with Diagnosed HFpEF
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-000830
Sponsor Protocol Number: 18-000830
About this study
The purpose of this study is to examine whether people without HFpEF display less visceral adipose tissue (VAT) compared to patients with diagnosed HFpEF.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult Participants, non-HFpEF (25 prospectively enrolled)
- Adult controls (>18 years) age, sex, and BMI matched without signs or symptoms of heart failure, confirmed via limited echocardiogram and physical examination.
- Data retrospectively collected from 25 Adult Participants with HFpEF (≥3 months), age 40-85 years who were enrolled in study 16-001467, defined by:
- Signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF as met by at least 1 of the following 4 criteria:
- Hospitalization for decompensated HF in the past year but not within the past 30 days;
- Invasively-documented elevated pulmonary capillary wedge pressures (PCWP) at rest (>15 mmHg) or with exercise (≥25 mmHg) at catheterization performed in the evaluation of dyspnea;
- Elevated NT-proBNP (>400 pg/mL) or BNP (>200 pg/mL);
- Echocardiographic evidence of HFpEF based upon current diagnostic guidelines(≥2 of the following: [a] E/e’≥15, [b] ≥moderate left atrial enlargement, [c] PASP >35 mm Hg).
Exclusion Criteria:
- Adult Participants, non-HFpEF
- Signs and symptoms of HF (dyspnea, fatigue), reduced left ventricular (LV) EF (≤50% within 12 months of enrollment), and objective evidence of HF as met by at least 1 of the following 4 criteria:
- Hospitalization for decompensated HF in the past year but not within the past 30 days;
- Invasively-documented elevated pulmonary capillary wedge pressures (PCWP) at rest (>15 mmHg) or with exercise (≥25 mmHg) at catheterization performed in the evaluation of dyspnea;
- Elevated NT-proBNP (>400 pg/mL) or BNP (>200 pg/mL);
- Echocardiographic evidence of HFpEF based upon current diagnostic guidelines40 (≥2 of the following: [a] E/e’≥15, [b] ≥moderate left atrial enlargement, [c] PASP >35 mm Hg).
- Data retrospectively collected from 25 Adult Participants with HFpEF (≥3 months), age 40-85 years who were enrolled in study 16-001467, defined by:
- Inability/unwillingness to engage in ET
- Recent (<1 months) HF hospitalization
- Concomitant treatment with organic nitrates or phosphodiesterase 5 inhibitors
- Prior EF <50%, BMI <20 or >50 kg/m2
- Acute coronary syndrome or revascularization within 3 months
- Infiltrative, hypertrophic, or radiation-induced cardiomyopathies
- Constrictive pericarditis
- Dyspnea felt to be due to primary lung disease or myocardial ischemia
- Severe anemia (Hgb <8.0)
- Systolic BP <110 mm Hg at consent
- Recent (<30 day) change in diuretics/vasoactive medications
- Significant left-sided valvular heart disease (>mild stenosis, >moderate regurgitation)
- Complex congenital heart disease
- Severe renal (estimated GFR<30) or hepatic disease
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Thomas Olson, Ph.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available