NCT02467296

Brief Summary

Currently, the recommendations for sodium intake restriction for patients with heart failure are mostly based on expert consensus and observational evidence, whereas smaller randomized studies have actually suggested that strict dietary sodium reduction may be harmful in heart failure. In the present clinical trial pilot study, the investigators plan to collect data on enrollment rates, compliance, outcomes, and safety of a 12-week dietary intervention in heart failure patients, with prepared food containing two different levels of sodium (1,500 mg and 3,000 mg) daily, followed by a 12-week surveillance for safety and effectiveness. The goal is to inform the design of a fullscale clinical trial that will provide more definitive evidence for dietary sodium recommendations in heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

June 3, 2015

Last Update Submit

September 23, 2019

Conditions

Heart Failure

Keywords

Sodiumoutcomes

Outcome Measures

Primary Outcomes (1)

  • Patient On-Study Retention

    Percentage of patients retained in the study

    3 month meal plan

Secondary Outcomes (6)

  • All cause mortality

    6 months follow up period

  • Rehospitalization

    6 months follow up period

  • Emergency room visits

    6 months follow up period

  • NT-proBNP

    6months follow up period

  • Kansas City Cardiomyopathy Questionnaire

    6 months follow up period

  • +1 more secondary outcomes

Other Outcomes (3)

  • Systolic Blood Pressure

    6 month follow up

  • Creatinine

    6 month follow up

  • Blood Urea Nitrogen

    6 month follow up

Study Arms (2)

A: 1.5 gr of Sodium

ACTIVE COMPARATOR

Meal Plans with 1.5 gr of Sodium

Other: Dietary plan with controlled amount of Sodium

B: 3 gr of Sodium

ACTIVE COMPARATOR

Meal Plans with 3 gr of Sodium

Other: Dietary plan with controlled amount of Sodium

Interventions

Dietary plan with controlled amount of SodiumOTHER

Dietary plan with 1.5 gr vs 3 gr of Sodium

A: 1.5 gr of SodiumB: 3 gr of Sodium

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥21 years at screening
  • Recent (≤1 year) EF ≤40%
  • Standard HF treatment, including ACEI/ARB \& beta-blockers \& aldosterone antagonists, unless contraindicated or intolerant
  • \. Able to consume research diet (e.g. no dysphagia etc.) 6. Systolic blood pressure ≥100 mmHg 7. \>3000 mg/d sodium excretion (by 24-hr urinary sodium)

You may not qualify if:

  • Institutionalized patients
  • Siogns or symptoms of instability in HF status
  • Communication barriers, including cognitive impairment; inability to communicate and understand and cooperate with the protocol
  • Severe non-cardiac illness that compromises life expectancy within the next 12 months or the ability to participate in the study (e.g. severe hepatobiliary disease, cancer underground chemo- or radiotherapy)
  • Any medical or surgical procedure planned in the next 6 months
  • Participants planning to move to a different state within 6 months
  • Participation in any other experimental protocol
  • Renal replacement therapy or Stage 4 or 5 chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • Kalogeropoulos A, Papadimitriou L, Georgiopoulou VV, Dunbar SB, Skopicki H, Butler J. Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study. Circ Heart Fail. 2020 Jan;13(1):e006389. doi: 10.1161/CIRCHEARTFAILURE.119.006389. Epub 2020 Jan 21.

    PMID: 31959014DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Javed Butler, MD, MPH, MBA

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH, MBA

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 10, 2015

Study Start

February 1, 2015

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)