Blood Pressure in Dialysis Patients

NCT01421771 | Completed Results DMC

• 1 other identifier: 1R01DK083424-01A1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 21

Brief Summary

Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (\<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.

Conditions

Hypertension; Renal Failure Chronic Requiring Hemodialysis; Blood Pressure; Dialysis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal

  one year

Secondary Outcomes (1)

• Number or Participants Assessed for Change in LV Mass

  One year

Study Arms (2)

Treatment to an intensive BP goal

ACTIVE COMPARATOR

Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg

Drug: Antihypertensive Agents; Other: Dry weight Challenge; Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight

Treatment to standard BP goal

PLACEBO COMPARATOR

Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg

Drug: Antihypertensive Agents; Other: Dry weight Challenge; Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight

Interventions

Antihypertensive Agents DRUG

Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator

Treatment to an intensive BP goal; Treatment to standard BP goal

Dry weight Challenge OTHER

Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal

Treatment to an intensive BP goal; Treatment to standard BP goal

Extend dialysis treatment time and re-challenge estimated dry weight DIETARY_SUPPLEMENT

Extend dialysis treatment time and re-challenge estimated dry weight

Treatment to an intensive BP goal; Treatment to standard BP goal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• On thrice weekly maintenance hemodialysis for greater than 90 days
• For entry into baseline period: 2-week average RDUSBPM \> 155 mm Hg on AHT medications or \< 155 mm Hg on ≥ 1 AHT medications For randomization: 2-week average SDUSBPM ≥ 155 mm Hg

You may not qualify if:

• Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
• Inability to measure blood pressures in an upper arm;
• History of inter or post-dialytic hypotension (defined as systolic blood pressure \<90 mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring hospitalization (including emergency room visit) and/or the use of midodrine in the past 6 months;
• Required one or more urgent, unscheduled dialysis treatment for congestive heart failure in the past 3 months (other than in an incident patient at the time of starting dialysis);
• Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
• Severe aortic valve stenosis (valve area \<1cm 2) carotid artery stenosis (\>70% stenosis);
• Known abdominal aortic aneurysm \>5 cm in diameter or thoracic aortic aneurysm of any diameter;
• Body mass index \>40 kg/m2 or arm circumference \> 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff;
• Life expectancy \<1 year;
• A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within the next year;
• Significant cognitive impairment;
• spKt/V ≤1.2 in the past 2 months;
• Active liver disease;
• Active alcohol or substance abuse including narcotics within the past year;
• Contraindication to cardiac MRI;

Sponsors & Collaborators

• University of New Mexico: lead
• Tufts Medical Center: collaborator
• Medical University of South Carolina: collaborator
• University of Pittsburgh Medical Center: collaborator
• The Cleveland Clinic: collaborator
• Case Western Reserve University: collaborator

Study Sites (21)

Dialysis Clinic Inc - Boston

Boston, Massachusetts, 02111, United States

Location

DaVita Boston

Boston, Massachusetts, 02118, United States

Location

Dialysis Clinic Inc - Walden Pond Clinic

Concord, Massachusetts, 01742, United States

Location

Dialysis Clinic Inc - Faulkner

Jamaica Plain, Massachusetts, 02130, United States

Location

Dialysis Clinic Inc - Somerville

Somerville, Massachusetts, 02145, United States

Location

Dialysis Clinic Inc - Albuquerque

Albuquerque, New Mexico, 87102, United States

Location

Dialysis Clinic Inc - Albuquerque South

Albuquerque, New Mexico, 87105, United States

Location

Dialysis Clinic Inc - Albuquerque East

Albuquerque, New Mexico, 87110, United States

Location

Dialysis Clinic Inc - Grants

Grants, New Mexico, 87020, United States

Location

Dialysis Clinic Inc - Rio Rancho

Rio Rancho, New Mexico, 87124, United States

Location

Centers for Dialysis Care East

Cleveland, Ohio, 44106, United States

Location

Centers for Dialysis Care - Shaker Heights

Cleveland, Ohio, 44122, United States

Location

Dialysis Clinic Inc - Oakland

Pittsburgh, Pennsylvania, 15213, United States

Location

Dialysis Clinic Inc - Banksville

Pittsburgh, Pennsylvania, 15216, United States

Location

Dialysis Clinic Inc - Point Breeze

Pittsburgh, Pennsylvania, 15221, United States

Location

Dialysis Clinic Inc - North Hills

Pittsburgh, Pennsylvania, 15237, United States

Location

Dialysis Clinic Inc - Magnolia Court

Charleston, South Carolina, 29403, United States

Location

Dialysis Clinic Inc - West Ashley

Charleston, South Carolina, 29407, United States

Location

Dialysis Clinic Inc - James Island

Charleston, South Carolina, 29412, United States

Location

Dialysis Clinic Inc - East Cooper

Mt. Pleasant, South Carolina, 29464, United States

Location

Dialysis Clinic Inc - Azalea Place

North Charleston, South Carolina, 29406, United States

Location

Related Publications (1)

• Miskulin DC, Gassman J, Schrader R, Gul A, Jhamb M, Ploth DW, Negrea L, Kwong RY, Levey AS, Singh AK, Harford A, Paine S, Kendrick C, Rahman M, Zager P. BP in Dialysis: Results of a Pilot Study. J Am Soc Nephrol. 2018 Jan;29(1):307-316. doi: 10.1681/ASN.2017020135. Epub 2017 Dec 6.

  PMID: 29212839 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Antihypertensive Agents

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Samiha Mateen
• Organization: University of New Mexico Health Sciences Center

smateen@salud.unm.edu

505-272-6057

Study Officials

• Philip Zager, MD

  University New Mexico

  STUDY CHAIR

• Dana Miskulin, PhD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

• Jennifer Gassman, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• David Ploth, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Manisha Jhamb

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Mahboob Rahman

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 23, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Locations

US (21)