Heredity and Phenotype Intervention (HAPI) Heart Study

NCT00664040 | Completed DMC

• 3 other identifiers: HP-00040375U01HL072515U01HL072515-05
• Study Type: interventional
• Target: 868
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death in the United States and many people that die of heart disease have no previous symptoms. This study will look specifically at the response to four short-term environmental exposures including: the body's response to a cold stimulus, to a high fat milk shake, to aspirin, and to a high and low salt diet. These interventions are all known to influence CVD and people can have different responses to these interventions, which may be due, at least in part, to differences in genetic make up.

Conditions

Cardiovascular Diseases

Interventions

Aspirin OTHER

The aspirin intervention (81 mg per day) will last a total of 14 days. Pills will be provided in a pre-loaded pillbox. The field team will visit the subject at his/her home at least once to insure adherence to the aspirin intervention and to monitor for adverse side effects. On day 14 of the aspirin intervention, the subject will visit the clinic for a fasting blood draw for platelet aggregation and inflammatory marker studies. A pill count will be performed to assess adherence. The subject can miss up to four aspirin doses over the two-week period; however, an aspirin must be taken each day for the three days prior to clinic visit 2. The aspirin intervention can be extended for up to three days (17 days total) to meet the latter criteria. If more than four doses were missed, then the physician should be contacted and the patient should be withdrawn from the aspirin intervention. Platelet aggregation will be measured 1 hour after the last dose of aspirin.

Cold Pressor Test OTHER

This intervention consists of the participant placing his or her hand and wrist into ice water for 2½ minutes. The blood pressure is taken before and after the arm is removed from the water. An ultrasound machine is used to take pictures of the brachial artery in the left arm before and after the arm is removed from the water.

High Fat Meal OTHER

The participants are given a high fat milk shake consisting of 83% fat. Blood samples are drawn from a catheter placed in the participant's arm prior to the test. The samples are drawn before the milk shake and at 1, 2, 3, 4, and 6 hours after the milk shake is consumed. Before and at 2, 4 and 6 hours following the meal the ultrasound is used to obtain images of the brachial artery.

Dietary Salt OTHER

The salt intervention will consist of 6 days of an isocaloric high salt diet (270 mmol/d) followed by a washout period of at least 8 days and then a low salt diet (40 mmol/d). All food will be prepared by a registered dietician and dietary technicians in a specially equipped kitchen. The specific foods will consist of approximately 50% carbohydrates, 35% fat, and 15% protein. Dietary potassium will remain constant at 120 mmol/d. A food diary will be kept for each diet and subjects will be instructed to eat only the food provided. A field nurse will visit the home on days 3 and 5 of each diet to insure that neither diet is acutely affecting the health status of the subject. A first AM void spot urine will be obtained to measure sodium, potassium and creatinine on the 4th, 5th, and 6th days of each diet to insure compliance. Blood pressure will be measured using an ambulatory blood pressure monitor for 24 hours on the last day of each diet.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant of Amish Family Calcification Study or related to a AFCS participant and at least 20 years old.

You may not qualify if:

• Excluded for the entire study if the subject-
• Is currently pregnant; however they will become eligible six months after delivery.
• Has severe hypertension (bp \> 180/105), making it unethical not to recommend prompt treatment.
• Takes medications that would affect the outcome(s) to be measured and cannot willingly and safely, in the opinion of the treating physician and study physician, discontinue these medications for 1 week prior to protocol initiation. These medications include anti-hypertensive agents (e.g., beta-blockers, calcium channel antagonists, ACE inhibitors, and diuretics), lipid lowering agents, nitrates, systemic glucocorticoids, adrenergic or cholinergic-acting agents including cold formulas and antidepressants, and diet/weight loss agents.
• Is taking vitamins and are unwilling to discontinue their use for at least 1 week prior to study.
• Has a coexisting malignancy
• Has a creatinine greater than 2.0, AST or ALT greater than 2 times the upper limit of normal, Hct less than 32, or a TSH less than 0.4 or greater than 5.5.
• Excluded from the Cold Pressor Test if the subject-
• \. Has Raynaud's disease or symptoms
• Excluded from the High Fat Challenge if the subject-
• Has a malabsorption disorder or lactose intolerance
• Has symptoms of gall bladder disease or history of pancreatitis
• Excluded from the Dietary Salt Intervention if the subject-
• Has stage III or greater congestive heart failure
• Has food allergies to foods included in the diet

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Aspirin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: May 1, 2003
• Study Completion: August 1, 2006
• Last Updated: July 26, 2022

Record last verified: 2022-07