NCT02527837

Brief Summary

The purpose of this study is to investigate how the effect of infused sodium nitrite differs in hypertensives compared to healthy age and sex matched controls. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started May 2015

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

February 18, 2015

Last Update Submit

August 17, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Fractional urinary sodium excretion (FENa)

    1 day

Secondary Outcomes (18)

  • Peripheral (brachial) blood pressure

    1 day

  • Central aortic systolic blood pressure (CASP)

    1 day

  • Plasma concentration of nitrite and nitrate (NOx)

    1 day

  • Urinary excretion of nitrite and nitrate (NOx)

    1 day

  • Glomerular filtration rate

    1 day

  • +13 more secondary outcomes

Study Arms (2)

Sodium nitrite

ACTIVE COMPARATOR

Sodium nitrite, 240 micrograms/kg/hour for 2 hours

Drug: Sodium nitrite

Placebo

PLACEBO COMPARATOR

Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours

Drug: Sodium chloride

Interventions

Sodium nitriteDRUG

Sodium nitrite, 240 micrograms/kg/hour for 2 hours

Also known as: NaNO2
Sodium nitrite
Sodium chlorideDRUG

Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours

Also known as: NaCl
Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18.5-30.0
  • Ambulatory daytime blood pressure \>135 mmHg systolic and/or \>85 mmHg diastolic
  • Women of childbearing potential must use safe contraception

You may not qualify if:

  • Tobacco smoking, medicine or substance abuse
  • Weekly consumption of more than 14 units (12 g alcohol per unit) for women and 21 units for men
  • Pregnancy or nursing
  • Neoplasia
  • Clinically significant heart, lung, liver, kidney, metabolic or neurologic disease
  • Albuminuria \> 300 mg/L
  • Renography with signs of renal artery stenosis or hydronephrosis
  • Clinically signs of secondary hypertension
  • Clinically significant hypokalemia
  • Clinically significant anemia
  • Estimated glomerular filtration rate (eGFR) \< 60 ml/min
  • Clinically significant findings in screening blood samples, urine sample or ECG
  • Persistent office blood pressure \> 170/105 mmHg on the maximum dose of amlodipine (10 mg daily)
  • Unacceptable symptoms of elevated blood pressure
  • Unacceptable side effects of amlodipine
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research and Medicine, Holstebro Regional Hospital

Holstebro, Holstebro, 7500, Denmark

RECRUITING

Related Publications (1)

  • Rosenbaek JB, Hornstrup BG, Jorgensen AN, Mortensen J, Pedersen EB, Bech JN. Effects of sodium nitrite on renal function and blood pressure in hypertensive vs. healthy study participants: a randomized, placebo-controlled, crossover study. J Hypertens. 2018 Mar;36(3):666-679. doi: 10.1097/HJH.0000000000001598.

    PMID: 29065098DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Sodium NitriteSodium Chloride

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Erling B Pedersen, MD, DMSc

    Holstebro Regional Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeppe B Rosenbaek, MD

CONTACT

+4578436585jepros@rm.dk

Erling B Pedersen, MD, DMSc

CONTACT

+4578436840ebp@dadlnet.dk

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician, professor, DMSc

Study Record Dates

First Submitted

February 18, 2015

First Posted

August 19, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-02

Locations

DK(1)