Status:

RECRUITING

GENESIS: Genotype Guided - Natriuretic Peptides - Cardiometabolic Health Study

Lead Sponsor:

University of Alabama at Birmingham

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Cardiovascular Diseases

Natriuretic Peptides

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Natriuretic Peptides (NP) are hormones produced by the heart, and they have a wide range of favorable metabolic benefits. Lower levels of these hormones are associated with an increased likelihood of ...

Detailed Description

The heart plays an endocrine role by secreting hormones called Natriuretic Peptides (NPs). NPs directly regulates blood pressure (BP) by causing dilation of blood vessels and removing sodium and water...

Eligibility Criteria

Inclusion

  • Adults: Age more than or equal to 18; an equal number of Males and Females
  • Consent to the collection of genetic material
  • Willing to adhere to the study protocol

Exclusion

  • Age \<18, at screening.
  • BMI \>45 kg/m2.
  • Blood pressure more than 140/90 mmHg.
  • Participants who are taking more than 2 hypertension medications.
  • History of diabetes or fasting plasma glucose \>126 mg/dl or HbA1C\>=6.5% or prior treatment with antidiabetic medication.
  • Have any past or present history of cardiovascular diseases (stroke, seizure, myocardial infarction, heart failure, transient ischemic attack, angina, or cardiac arrhythmia)
  • Women who are pregnant or breastfeeding or who can become pregnant and not practicing an acceptable method of birth control during the study (including abstinence);
  • Estimated GFR \< 60 ml/min/1.73 m2; albumin creatinine ratio ≥30 mg/g
  • Hepatic Transaminase (AST and ALT) levels \>3x the upper limit of normal
  • Anemia (men, Hct \< 38%; women, Hct \<36%)
  • Inability to exercise on a treadmill

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 30 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05216042

Start Date

April 1 2022

End Date

April 30 2027

Last Update

July 3 2025

Active Locations (1)

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1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294